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Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT)

This study has been completed.
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01066078
First received: February 9, 2010
Last updated: March 4, 2010
Last verified: March 2010
History of Changes
  Purpose

This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.


Condition Intervention
Congestive Heart Failure
 Other: Echocardiography and SonR recording

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Echocardiography and PEA Measurements in CRT Therapy

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CRT recipients Other: Echocardiography and SonR recording

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

CRT recipients

Criteria

Inclusion Criteria:

  • Every patient coming in the participating centers for an echocardiographic exam and implanted with a pacemaker or an implantable cardioverter defibrillator (ICD) can be included in the study.

Exclusion Criteria:

  • Inability to understand the patient information sheet.
  • Minor patient or pregnant woman.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066078

Locations
France
Nouvelles Cliniques Nantaises
Nantes, France
Clinique Bizet
Paris, France, 75016
CHU Rennes
Rennes, France
CHU Pontchaillou
Rennes, France
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: Erwan DONAL, MD CHU Rennes
  More Information

No publications provided

Responsible Party: Erwan DONAL, CCP, CHU Pontchaillou 35033 RENNES France
ClinicalTrials.gov Identifier: NCT01066078     History of Changes
Other Study ID Numbers: RGEA01 - CAP PEA, RGEA01
Study First Received: February 9, 2010
Last Updated: March 4, 2010
Health Authority: France: French Data Protection Authority

Keywords provided by Sorin Group:
heart failure - congestive
Cardiovascular imaging agents/Techniques]
Echocardiography
 Other diagnostic testing
Other Treatment
Recipients of cardiac resynchronization therapy systems

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013